Decathlon DF Long-Term Hemodialysis Catheter DF19IT24KRecalls & reported problems
Bard Access Systems, Inc. · DECATHLON DF HEMODIALYSIS CATH, INTERMEDIATE KIT, AIRGUARD, 16FR. 19cm · Class 2 · Implant
All models of Decathlon DF Long-Term Hemodialysis Catheter (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741013935), received between Sep 20, 2019 and Nov 14, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Deformation Due to Compressive Stress1
- Failure to Advance1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 14, 2024Failure to Advance; Deformation Due to Compressive Stress; Failure to Advance; Deformation Due to Compressive Stress
IT WAS REPORTED THAT DURING A PREPARATION OF DIALYSIS PLACEMENT PROCEDURE IN THE RIGHT INTERNAL JUGULAR VEIN FOR HEMODIALYSIS ACCESS, THE CATHETER WAS ALLEGEDLY KINKED. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY FAILED TO ADVANCE OVER THE WIRE. THE PROCEDURE WAS COMPLETED USING SAME DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20681428 ↗MalfunctionSep 20, 2019Break; Break
IT WAS REPORTED THAT UPON OPENING THE DIALYSIS CATHETER KIT THE ARTERIAL LUMEN OF THE CATHETER WAS ALLEGEDLY FOUND TORN. IT WAS FURTHER REPORTED THAT ANOTHER KIT WAS USED TO PERFORM THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9101146 ↗
Other Catheter, hemodialysis, implanted devices
- Palindrome 8888145014Mozarc Medical US LLC · Catheter, hemodialysis, implanted1 recall312 reports
- Palindrome 8888145015Mozarc Medical US LLC · Catheter, hemodialysis, implanted2 recalls1 death219 reports
- HemoStar Long-Term Hemodialysis Catheter 5833690Bard Access Systems, Inc. · Catheter, hemodialysis, implanted2 deaths290 reports
- Palindrome 8888119369PMozarc Medical US LLC · Catheter, hemodialysis, implanted3 recalls1 death14 reports
- HemoStar Long-Term Hemodialysis Catheter 5833730Bard Access Systems, Inc. · Catheter, hemodialysis, implanted1 death141 reports
- GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet 5393230Bard Access Systems, Inc. · Catheter, hemodialysis, implanted5 deaths138 reports
- Palindrome 8888123404PMozarc Medical US LLC · Catheter, hemodialysis, implanted2 recalls1 death17 reports
- Palindrome 8888119364PMozarc Medical US LLC · Catheter, hemodialysis, implanted2 recalls1 death17 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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